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June 27, 2023

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Annex 1 Environmental Monitoring Common Questions and Answers

The newly published Annex 1 comes into effect this August 2023. Particle Measuring Systems have been involved in discussions with industry and regulatory focused teams defining how best to address the new elements of environmental monitoring to meet these new requirements. Join environmental monitoring expert Mark Hallworth as he shares frequently received questions along with practical answers to help you meet your EM needs.

	Industry News

Anavex Life Sciences and Partex Group to Leverage AI for Drug Development and Marketing
Anavex Life Sciences Corp. and Partex N.V. Group announced a strategic partnership with the overall ... read more »

Arch Biopartners Receives FDA Permission to Proceed with Kidney Trial
Arch Biopartners Inc. announced that it received a “Study May Proceed” letter from the FDA for a ... read more »

AC Immune Receives FDA Fast Track Designation for Alzheimer’s Treatment
AC Immune SA it has received Fast Track designation from the FDA for its wholly-owned anti-amyloid ... read more »

FDA Issues Draft Guidance About Formal Dispute for OTC Monograph Drugs
The FDA issued draft guidance for industry titled “Formal Dispute Resolution and Administrative ... read more »

	QC Corner

QC Corner: Automated Data Integrity in Sterility Testing
Pharma 4.0 transformation processes are reaching microbiological QC labs, using automation, robotics... read more »

	Infographic

Extractables and Leachables Testing for (Bio)Pharmaceuticals
This infographic breaks down some of the most important terms and definitions of the E&L process. Download this infographic to learn more. read more »

	Featured Articles

		Reducing LAL Usage in Compliant Endotoxin Assays In recent years, there have been major improvements and advancements in pharmaceutical technology with regards to quality control testing. One test ... read more »

		An interview with: Chris Miller - President, Global Business Unit, Biopharma and Life Science, Exyte Exyte offers the full suite of engineering, design, procurement, construction, construction management, qualification and validation services to ... read more »

	Featured Video

On-Demand Webinar: Annex 1 Environmental Monitoring Common Questions and Answers
In this live webinar, hear from Mark Hallworth, GMP Scientific Advisor from Particle Measuring Systems as he addresses Annex 1 Environmental ... watch »

Pharma Flash - Merck Wins Patent Suit, Harvard Drug Group Recall and more
Watch the Pharma Flash for these stories and more including news on acquisitions, facility openings and other news about your industry. watch »

	Featured Products

BRAND® HandyStep® Touch Electronic Repeating Pipette
BRANDTECH® Scientific The BRAND® HandyStep® Touch and Touch S are the first electronic repeating pipettes with touchscreen... learn more »

PURELAB® Chorus 1 Complete Ultrapure Water System
ELGA LabWater | Veolia One complete solution for the laboratoryPURELAB® Chorus 1 Complete provides a complete solution from... learn more »

Acconon Mixtures for Bioavailability and Emulsion
ABITEC Acconon excipients are well-characterized mixtures of polyoxyethylene mono- and diglycerides, fatty ... learn more »

	Featured Whitepaper

Whitepaper: Adopting the Monocyte Activation Test for Sustainable Pyrogen Testing
Adopting the Monocyte Activation Test (MAT) for rabbit-free pyrogen testing of pharmaceutical preparations is highly encouraged for meeting product safety demands. This White Paper draws on an ... read more »

Whitepaper: The Relevance of Polymorph Screening in the Pharmaceutical Industry
Solid form screening, the activity of discovering and characterizing different solid forms of an active pharmaceutical ingredient (API), is an essential part of drug development. This screening ... read more »

	More Products

Cary 60 UV-Vis Spectrophotometer Learn More
Cleanroom Particle Counter: Lasair® III Learn More
Ambr® 250 High Throughput Multi-Parallel Bioreactor Learn More

	Directory Categories

Dosage Form Search More

Formulation Development Search More

Pharmaceutical Excipients Search More

	Events

CRS 2023 Annual Meeting
Las Vegas, Nevada, USA – 07/24/2023
The 2023 Annual Meeting & Expo reflects our focus on cutting-edge research and innovation across our strong discipline that will keep you up-to-date ... event details »

Eastern Analytical Symposium 2023
Plainsboro, NJ – 11/13/2023
Each year the Eastern Analytical Symposium honors Analytical Chemists who have distinguished career achievements. event details »

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